Teriflunomide Patent Expiration

Teriflunomide is Used for treating patients with relapsing forms of multiple sclerosis. It was first introduced by Sanofi Aventis Us Llc in its drug Aubagio on Sep 12, 2012. 20 different companies have introduced drugs containing Teriflunomide.


Teriflunomide Patents

Given below is the list of patents protecting Teriflunomide, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Aubagio US9186346

(Pediatric)

Methods for reducing the risk of an adverse teriflunomide and rosuvastatin interaction in multiple sclerosis patients Aug 04, 2034 Sanofi Aventis Us
Aubagio US9186346 Methods for reducing the risk of an adverse teriflunomide and rosuvastatin interaction in multiple sclerosis patients Feb 04, 2034 Sanofi Aventis Us
Aubagio US8802735

(Pediatric)

(Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4'-trifluormethylphenyl)-amide tablet formulations with improved stability Mar 14, 2031 Sanofi Aventis Us
Aubagio US8802735 (Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4'-trifluormethylphenyl)-amide tablet formulations with improved stability Sep 14, 2030 Sanofi Aventis Us
Aubagio US6794410

(Pediatric)

Use of (Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4′-trifluoromethylphenyl)-amide for treating multiple sclerosis Mar 12, 2027 Sanofi Aventis Us
Aubagio US6794410 Use of (Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4′-trifluoromethylphenyl)-amide for treating multiple sclerosis Sep 12, 2026

(Expired)

Sanofi Aventis Us
Aubagio US5679709 Medicaments to combat autoimmune diseases Oct 21, 2014

(Expired)

Sanofi Aventis Us
Aubagio US5459163 Medicament to combat autoimmune diseases Oct 17, 2012

(Expired)

Sanofi Aventis Us



Teriflunomide's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Teriflunomide:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS) Hoffmann-La Roche NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE3
Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS) Hoffmann-La Roche NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE3
A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis. Sanofi NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3
Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis Sanofi NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE3
Teriflunomide in HTLV-1 Associated Myelopathy/Tropical Spastic Paraparesis National Institute of Neurological Disorders and Stroke (NINDS) NA RECRUITING
(Jun 17, 2026)
PHASE1, PHASE2


Teriflunomide Generic API Manufacturers

Several generic applications have been filed for Teriflunomide. The first generic version for Teriflunomide was by Watson Laboratories Inc An Indirect Wholly Owned Sub Of Teva Pharmaceuticals Usa Inc and was approved on Jul 27, 2018. And the latest generic version is by Neocubes Pharma Llp and was approved on Apr 7, 2025.

Given below is the list of companies who have filed for Teriflunomide generic, along with the locations of their manufacturing plants worldwide.